LifeScience Regulatory Svs Analyst

Skill required: Regulatory Operations - Life Sciences Regulatory Operations



Designation: LifeScience Regulatory Svs Analyst



Qualifications:Bachelor of Pharmacy/Master of Pharmacy



Years of Experience:3 to 5 years



What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.



What are we looking for?

Agility for quick learning

Problem-solving skills

Ability to perform under pressure

Commitment to quality

Ability to work well in a team


Roles and Responsibilities:

In this role you are required to do analysis and solving of lower-complexity problems

Your day to day interaction is with peers within Accenture before updating supervisors

In this role you may have limited exposure with clients and/or Accenture management

You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments

The decisions you make impact your own work and may impact the work of others

You will be an individual contributor as a part of a team, with a focused scope of work

Please note that this role may require you to work in rotational shifts



Qualifications

Bachelor of Pharmacy,Master of Pharmacy